NZNP Finance Ltd. v. Actavis Laboratories UT, Inc. (Fed. Cir. 2020)

By Donald Zuhn --

On Tuesday, the Federal Circuit issued a per curiam Order in NZNP Finance Ltd. v. Actavis Laboratories UT, Inc., denying a petition for rehearing en banc filed by Plaintiffs-Appellants HZNP Finance Ltd. and Horizon Therapeutics USA, Inc.  The Court also denied Plaintiffs-Appellants a panel rehearing.

Circuit Judge Lourie, joined by Circuit Judges Newman, O'Malley, and Stoll, dissented from the denial of the petition for rehearing en banc, arguing that the panel majority had "erroneously misconstrued the 'consisting essentially of' language in evaluating the definiteness requirement of 35 U.S.C. § 112."  At issue was claim 49 of U.S. Patent No. 8,252,838, which reads:

49.  A topical formulation consisting essentially of:
    1–2% w/w diclofenac sodium;
    40–50% w/w DMSO;
    23–29% w/w ethanol;
    10–12% w/w propylene glycol;
    hydroxypropyl cellulose; and
    water to make 100% w/w,
    wherein the topical formulation has a viscosity of 500–5000 centipoise.

The panel majority had affirmed the determination by the District Court for the District of New Jersey that claim 49 was indefinite because of inconsistencies in the meaning of "better drying time."  The '838 patent specification discloses that the claimed formulation can be used as an anti-inflammatory, or analgesic.  The specification also discloses that the advantages of the claimed formulation are better drying time, higher viscosity, increased transdermal flux, greater pharmacokinetic absorption, and favorable stability.

The dissent begins by noting that "[i]t is not disputed that 'consisting essentially of' generally means that the composition not contain, in addition to its enumerated components, materials that materially affect the basic and novel properties of the invention."  The dissent points out that the term "better drying time" is not recited in the claim, adding that "it is the claims that the statute requires be definite."

With respect to claim 49, the dissent notes that "[t]he utility of the claimed invention, recited in the specification, is as an anti-inflammatory, or analgesic, because those are the principal properties of diclofenac, the main ingredient of the composition."  As for the advantage of better drying time, the dissent contends that "it is the language of the claims that must not be indefinite, not the understanding or clarity of an advantage of the invention," pointing out that "[t]he advantages of the invention, its utility and its basic and novel properties, are not in the claims."

Noting that it is not necessary to recite the utility of a claimed compound (e.g., as an anti-inflammatory) in the claims, nor is it necessary to recite in the claims how that utility is measured, the dissent concludes that "aspects of the utility or its measurement are not relevant to indefiniteness of the claims."  The dissent then asks "since how one measures anti-inflammatory activity does not create an indefiniteness issue, why should measuring better drying time?"  The dissent also wonders "whether, if this patent did not recite the methods by which better drying time was measured, any indefiniteness of the 'consisting essentially of' language would have arisen at all."  Because "under the rule this opinion purports to adopt, any uncertainty concerning advantages, utility, or methods of determining such could . . . be translated into indefiniteness of claims," Judge Lourie dissented from the Federal Circuit's decision not to rehear the case en banc.

NZNP Finance Ltd. v. Actavis Laboratories UT, Inc. (Fed. Cir. 2020)
Per curiam
Circuit Judge Lourie dissenting from the denial of the petition for rehearing en banc, joined by Circuit Judges Newman, O'Malley, and Stoll

Comments

[Atari Man]

Bravo for the dissenters. How did the Federal Circuit become populated with so many judges who willfully misread the statute? This result was not mandated by a Supreme Court decision, this is the CAFC choosing of its own volition to corrupt patent law.

[EG]

Hey Don,

The dissent and Judge Newman are correct that the term “consisting essentially of” has a well-established meaning. That the rest of the Federal Circuit suggests otherwise is a disgrace.

[Michael Mercanti]

I agree with the crowd here. The dissent got it right. It makes no sense to include the quicker drying time in the claim

[Paul Cole]

This illustrates the problems inherent in adjudication by judges inexperienced in technology and in patent law. The meaning of the term "consisting essentially of" has been well-established and recognised amongst practitioners for generations. The "all elements" rule also familiar to practitioners for generations but now commonly disregarded by the courts has the converse that features not mentioned in a claim are not claimed features and therefore cannot render the subject matter defined by the claim indefinite, as explained by the dissenting judges.

What is the point in the expenditure of professional time and skill in the drafting of claims intended to define with precision the subject-matter sought to be protected when their wording can be and often is utterly disregarded by the courts?: